Knife, Cervical Cone

Device Code: 3899

Product Code(s): HDZ

Device Classification Information

Device Type ID3899
Device NameKnife, Cervical Cone
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(k)
CFR Regulation Number884.4530 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHDZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3899
DeviceKnife, Cervical Cone
Product CodeHDZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
CFR Regulation Number884.4530 [🔎]
TPLC Last Update: 2019-04-02 20:39:43

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